Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies

NCT ID: NCT00246662

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-14
• Study Completion Date: 2009-04-30

Brief Summary

This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential biomarkers and antileukemic activity.

Detailed Description

Patients assigned to 1 of 2 schedules (A and B) in cohorts of at least 3 patients received vosaroxin (SNS-595) intravenously (IV) for up to 4 cycles: once weekly (Days 1, 8, 15 in Schedule A) or twice weekly (Days 1, 4, 8, 11 in Schedule B). Dose escalation proceeded independently for Schedule A (18 mg/m2 initially) and Schedule B (9 mg/m2 initially) in the absence of Dose-limiting Toxicity (DLT) based on a modified Fibonacci sequence. The incidence of DLT during Cycle 1 determined the maximum-tolerated dose (MTD) allowing for treatment delays of up to 14 days to resolve clinically significant abnormal laboratory values or related treatment-emergent adverse events (TEAEs) and one dose reduction of 25% in case of above. Patients with stable disease, hematologic improvement, or partial remission with stable blast counts or experiencing clinical benefit in the opinion of the investigator were eligible to receive vosaroxin for up to 4 additional cycles.

Conditions

Leukemia, Lymphocytic, Acute; Leukemia, Nonlymphocytic, Acute; Leukemia, Myeloid, Chronic; Myelodysplastic Syndromes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sch A (18 mg/m2 vosaroxin initially)

Once weekly intravenous on days 1, 8, 15 up to 4 cycles

Group Type: EXPERIMENTAL

Vosaroxin

Intervention Type: DRUG

All patients receive vosaroxin Injection

Sch B (9 mg/m2 vosaroxin initially)

Twice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles

Group Type: EXPERIMENTAL

Vosaroxin

Intervention Type: DRUG

All patients receive vosaroxin Injection

Interventions

Vosaroxin

All patients receive vosaroxin Injection

Intervention Type: DRUG

Other Intervention Names

SNS-595; Voreloxin

Eligibility Criteria

Inclusion Criteria

• Able to understand and willing to sign a written informed consent document
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, 0r 2
• Received less than or equal to 3 induction/re-induction regimens for disease(s) defined by the protocol
• Must have relapsed or refractory leukemia for which no standard therapies are expected to result in a durable remission; patients who have not received prior treatment who have either refused or, in the opinion of the Investigator, are not able to tolerate, standard therapy may be included.

Exclusion:

• Prior exposure to SNS-595 (vosaroxin)
• Pregnant or breastfeeding
• Women of childbearing potential or male partners of women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards
• Any evidence of active central nervous system (CNS) leukemia
• Any evidence of acute or chronic graft-versus-host disease
• Laboratory values outside normal or reasonable reference range specified by the protocol
• Liver function and kidney function outside limits specified by the protocol
• Not yet recovered from side effects of previous cancer therapy
• Myocardial infarction, cerebrovascular accident/transient ischemic attack (TIA) or thromboembolic event (deep vein thrombosis or pulmonary embolus) within 6 months before the first SNS-595 dose
• Requires kidney dialysis (hemodialysis or peritoneal)
• Received an investigational agent within 14 days before Cycle 1, Day 1
• Prior pelvic radiation therapy or radiation to greater than or equal to 25% of bone marrow reserve (palliative radiation is not excluded as long as it does not exceed greater than or equal to 25% of bone marrow reserve)
• Any other medical (uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety or compliance with study procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunesis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Michelson, MD

Role: STUDY_DIRECTOR

Sunesis Pharmaceuticals

Locations

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, United States

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

SPO-0004

Identifier Type: -

Identifier Source: org_study_id